Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | UT8781CA | OT / LA |
temperature excursion as max/low temperature reached: negative 7 °c to 5 °c for 4 hours and 30 minutes and product was administered after excursion with no adverse event; Initial information received on 17-Oct-2025 regarding an unsolicited valid non-serious case received from a Other Health Care Professional (Nursing supervisor). This case is linked to US-SA-2025SA311712 and US-SA-2025SA312041 This case involves 88 years old female patient and reporter reported temperature excursion as max/low temperature reached: negative 7 °c to 5 °c for 4 hours and 30 minutes and influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] was administered after excursion with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List of concomitant vaccines: No other vaccines On 15-Oct-2025, the patient received a dose of 0.5 ml of suspect influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (lot UT8781CA, expiry date- 30-JUN-2026) (Strength: High dose; Frequency: Once) via intramuscular route in the left deltoid for Influenza (Influenza immunization); which had temperature excursion as max/low temperature reached: negative 7 °c to 5 °c for 4 hours and 30 minutes and product was administered after excursion with no adverse event (product storage error). It was reported, ''Nursing supervisor called to report a temperature excursion and wanted stability information. Previous excursion: No. Human error involved. Product was administered. extended stability data did not cover the excursion. They said that the product was administered to three patients; Treatment: None ''. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA311712:02693089 US-SA-2025SA312041: